Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency would need to realign its programs. With very little detail it was revealed that it would be led by a Program Alignment Group (PAG) consisting of all executive-level members of each of the FDA’s regulatory centers, as well as the Office of Regulatory Affairs (ORA).

There was a talk given at a recent conference by a man named Rick Roberts, who has been a victim of both drug shortages and counterfeit drugs. Mr. Roberts grew up in small town in the US. Due to health problems, he had an inhaler from age one. Because of this, he had many trips to the pharmacy growing up and became very interested in the field, eventually deciding he wanted to be a pharmacist.
Mr. Roberts went to college in San Francisco, California, and unfortunately contracted...

Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply chain.

The FDA regulates products from more than 150 countries.

There are over 130,000 importers into the US, with over 300,000 foreign facilities providing these goods.

FDA regulated shipments at more than 300 US portshave quadrupled over ten years.

Finished drugs from overseas account for roughly 40% of Pharmaceuticals in the US

In 2008, approximatly 80% of Active Pharmaceutical Ingredients (APIs) were from foreign suppliers.

Under FDASIA the FDA will take different approaches. They may request extensive copies of records for review in lieu of actual site inspections. Products will be considered adulterated if they come from a company that has been found to be out of compliance at ANY location, not just the source of that...

DO!
• Include photos where possible.
• Include documentation to provide evidence that corrective actions have been implemented.
• Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask! If you had the observation at one site, but did not address it at all sites, you will need to make sure that you...

Observations related to complaint file handling make up a significant portion of 483 findings and Warning Letter observations for Medical Devices. In the 483 data released by the FDA for 2012 Device inspections, out of 1090 issued 483s, there are over 400 observations for different sections of 21 CFR 820.198, the regulations dealing with complaint files.

Out of 99 Warning Letters issued to Medical Device companies in 2013 (up to July 3rd, 2013), 50 have contained observations relating to Design Control (21 CFR 820.30) deficiencies, with a total of 85 observations. The three subcategories that received the most attention are (f)Design Verification (12 observations, or 24% of the Medical Device related Warning Letters), (g) Design...

Out of 99 Warning Letters issued to Medical Device companies in 2013 (up to July 3rd, 2013), 50 have contained observations relating to Design Control (21 CFR 820.30) deficiencies, with a total of 85 observations. The three subcategories that received the most attention are (f)Design Verification (12 observations, or 24% of the Medical Device related Warning Letters), (g) Design...

Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating to Corrective and Preventive Actions (CAPA) deficiencies 21 CFR 820.100. Of these 29 Warning...

Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software. Sounds pretty straight forward, right? But when we look at the customer’s user requirements documents, we realized that they were derived from user manuals and specification sheets that manufacturers provide for that equipment. Some requirements even read like advertising lingo and performance claims from a website....